This invention relates to reagents for use in methods, compositions and kits for determining specific IgE against the disaccharide epitope galactose-α-1,3-galactose in a sample.
Diagnosis of disease and determination of treatment efficacy are important tools in medicine. In particular, detection of IgE production in an animal can be indicative of disease. Immunoglobulin E (IgE) is the antibody subclass responsible for, among other things, allergic diseases and anaphylactic shock reactions. Measurement of IgE levels in the blood, tissue and body fluids of mammals is generally required for the accurate diagnosis of diseases relating to IgE production. Such diseases include, for example, allergy, atopic disease, hyper IgE syndrome, internal parasite infections and B cell neoplasia. In addition, detection of IgE production in an animal following a treatment involving administration of a medicament is indicative of the efficacy of the treatment, such as when using treatments intended to disrupt IgE production.
Cetuximab, a chimeric mouse-human IgG1 monoclonal antibody against the epidermal growth factor receptor, is approved by the Food and Drug Administration (FDA) for use in colorectal cancer that has spread to other parts of the body. A certain percentage of patients that receive cetuximab experience an adverse reaction to the drug. It is known that the presence of IgE antibodies specific for an oligosaccharide, galactose-α-1,3-galactose, which is present on the Fab portion of the cetuximab heavy chain, can lead to anaphylaxis and other adverse reactions in patients undergoing cetuximab therapy.